ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)

K051752 · Roche Diagnostics · MMI · Jul 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051752
• Device Name: ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)
• Applicant: Roche Diagnostics
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jul 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.

Device Story

The Elecsys Troponin T STAT assay is a two-step sandwich immunoassay utilizing streptavidin-coated microparticles and electrochemiluminescence (ECLIA) detection. It measures human Troponin T in serum or plasma samples. The device is intended for use by clinical laboratory professionals on Roche Elecsys family immunoassay analyzers. The assay transforms the presence of Troponin T into a light signal proportional to the analyte concentration. Healthcare providers use the quantitative output to diagnose acute myocardial infarction, stratify ACS patient risk, and manage patients with chronic renal failure. The test aids in clinical decision-making regarding the necessity for intensive cardiac interventions. Benefits include rapid, sensitive detection of cardiac necrosis to facilitate timely clinical management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to assess impact of reagent and specimen type modifications; results met predetermined acceptance criteria.

Technological Characteristics

Two-step sandwich immunoassay; electrochemiluminescence (ECLIA) detection; streptavidin-coated microparticles. Sample types: serum, K2/K3-EDTA, Li-heparin, Na-citrate plasma. Measuring range: 0.010-25.00 ng/mL. Analyzers: Roche Elecsys family. Reagent stability: 12 weeks opened at 2-8 °C. Contains additives to minimize interference from monoclonal mouse antibodies and anti-streptavidin antibodies.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for clinical laboratory testing; intended use remains unchanged from the previously cleared device.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Previously cleared device (K040733)

Submission Summary (Full Text)

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#### JUL 1 1 2005

K051752

# 510(k) Summary – Elecsys® Troponin T STAT Assay

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics 9115 Hague Rd Indianapolis IN 46250 [phone] |
| | Contact person: Theresa M. Ambrose |
| | Date prepared: June 28, 2005 |
| Device Name | Proprietary name: Elecsys® Troponin T STAT Assay |
| | Common name: Troponin T Test |
| | Classification name: Immunoassay method, troponin subunit |
| Device Description | The Elecsys® Troponin T STAT assay is a two step sandwich immunoassay with streptavidin micro particles and electrochemiluminescence detection, for the measurement of human TnT in serum or plasma . |
| Intended use | Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers. |
| Predicate Device | We claim substantial equivalence to the Elecsys ® Troponin T STAT reagent currently marketed on the Elecsys 2010 and MODULAR ANALYTICS E170. (K040733). |
| | Continued on next page |

Confidential

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## 510(k) Summary – Elecsys® Troponin T STAT Assay, Continued

The table below indicates the similarities and differences between the Substantial modified Elecsys® Elecsys Troponin T STAT and its predicate device equivalency -(current Troponin T STAT, K040733). device comparison

| Characteristic | Current Elecsys® Troponin T STAT<br>(3rd Gen.) (K040733) | Modified device Elecsys®<br>Troponin T STAT (4th Gen.) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Immunoassay for the in vitro<br>quantitative determination of troponin<br>T in human serum and plasma.<br>Elecsys Troponin T can be used as an<br>aid in the differential diagnosis of<br>acute coronary syndrome to identify<br>necrosis, e.g., acute myocardial<br>infarction. The test is further<br>indicated for the risk stratification of<br>patients presenting with acute<br>coronary syndrome and for cardiac<br>risk in patients with chronic renal<br>failure. The test may also be useful<br>for the selection of more intensive<br>therapy and intervention in patients<br>with elevated levels of cardiac<br>Troponin T. The<br>electrochemiluminescence<br>immunoassay "ECLIA" is intended<br>for use on the Roche Elecsys family<br>of immunoassay analyzers. | Same |
| Indications for Use | Elecsys Troponin T can be used as an<br>aid in the differential diagnosis of<br>acute coronary syndrome to identify<br>necrosis, e.g., acute myocardial<br>infarction. The test is further<br>indicated for the risk stratification of<br>patients presenting with acute<br>coronary syndrome and for cardiac<br>risk in patients with chronic renal<br>failure. The test may also be useful<br>for the selection of more intensive<br>therapy and intervention in patients<br>with elevated levels of cardiac<br>Troponin T. | Same |
| | | |
| Assay principle | Electrochemiluminescent<br>immunoassay | Same |
| Traceability/<br>standardization | Standardized against the 2nd generation Troponin T test | Standardized against the 3rd generation Elecsys Troponin T test; traceable to the 2nd generation test |
| Calibration frequency | Elecsys 2010<br>• After 1 month when using the same<br>reagent lot<br>• After 7 days when using the same<br>reagent kit on the analyzer<br>Elecsys 1010<br>• With every reagent kit<br>• After 7 days (20-25 °C)<br>• After 3 days (25-32 °C) | Elecsys 2010<br>• After 1 month when using the<br>same reagent lot<br>• After 7 days when using the same<br>reagent kit on the analyzer<br>Elecsys 1010<br>• With every reagent kit<br>• After 7 days (20-25 °C) |
| Sample type | Human serum, K3-EDTA and Na-<br>citrate plasma. | Human serum, K2- and K3-EDTA,<br>Li-heparin, and Na-citrate plasma |
| Reagent stability | Unopened<br>• Up to the stated expiration date at 2-<br>8 °C<br>After opening<br>• 12 weeks at 2-8 °C<br>• 8 weeks on Elecsys 2010<br>• 8 weeks on Elecsys 1010 (20-25 °C;<br>up to 20 hours opened in total) | Same |
| Calibrator | Elecsys Troponin T STAT CalSet | Same |
| Controls | Elecsys PreciControl Troponin T or<br>Elecsys PreciControl Cardiac. | Elecsys PreciControl Troponin T |
| Duration of assay | 9 minutes | Same |

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# Special 510(k): Device Modification – Elecsys® Troponin T

### STAT ,Continued

:

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### Special 510(k): Device Modification – Elecsys® Troponin T STAT ,Continued

.

| Measuring range | 0.010-25.00 ng/mL | Same |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | Within-run (human serum)<br>• 1.1% CV at 0.47 ng/mL<br>• 1.1% CV at 2.63 ng/mL<br>• 1.4% CV at 11.5 ng/mL<br>Within-run (PreciControl)<br>• 4.2% CV at 0.10 ng/mL<br>• 3.0% CV at 5.07 ng/mL<br>Total (human serum)<br>• 5.8% CV at 0.47 ng/mL<br>• 5.4% CV at 2.63 ng/mL<br>• 5.7% CV at 11.5 ng/mL<br>Total (PreciControl)<br>• 9.3% CV at 0.10 ng/mL<br>• 6.0% CV at 5.07 ng/mL | Within-run (human serum)<br>• 4.5% CV at 0.047 ng/mL<br>• 2.0% CV at 0.652 ng/mL<br>• 2.9% CV at 6.08 ng/mL<br>Within-run (PreciControl)<br>• 2.2% CV at 0.137 ng/mL<br>• 2.5% CV at 2.89 ng/mL<br>Total (human serum)<br>• 6.2% CV at 0.047 ng/mL<br>• 4.6% CV at 0.652 ng/mL<br>• 5.6% CV at 6.08 ng/mL<br>Within-run (PreciControl)<br>• 3.5% CV at 0.137 ng/mL<br>• 4.7% CV at 2.89 ng/mL |
| Concentration at 10%<br>CV: | 0.03 ng/mL | Same |
| Hook effect | No hook effect up to 400 ng/mL | Same |
| Analytical sensitivity | Lower detection limit: 0.01 ng/mL<br>Lowest concentration giving 10 %<br>CV: 0.03 ng/mL | Same |

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### Special 510(k): Device Modification – Elecsys® Troponin T

STAT ,Continued

| Limitations –<br>interference | No interference from<br>• icterus up to 27 mg/dL bilirubin<br>• hemolysis up to 0.1 g/dL,<br>• Lipemia up to 1500 mg/dL<br>Intralipid<br>• Biotin up to 50 ng/mL<br>• Rheumatoid factor up to 2000<br>U/mL | Same |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Falsely depressed results are obtained<br>when using samples with higher<br>hemoglobin concentrations. | Same |
| | Plasma samples collected with<br>heparin or oxalate/fluoride revealed<br>sample-dependent low TnT values<br>compared to results obtained on<br>serum samples. | Plasma samples collected using<br>tubes containing oxalate/fluoride<br>revealed sample-dependent low<br>TnT values when compared to<br>results obtained on serum samples. |
| | Contains additives to minimize the<br>effects of interference due to<br>• Monoclonal mouse antibodies<br>• Antibodies to streptavidin | Same |
| | Extremely high titers of antibodies to<br>ruthenium can cause interference. | Same |
| | Results should be assessed in<br>conjunction with the patient's medical<br>history, clinical examination, and<br>other findings | Same |

. I

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 1 2005

Theresa M. Ambrose, Ph.D., RAC Regulatory Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250

Re: k051752

Trade/Device Name: Roche Elecsys® Troponin T STAT Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: MMI Dated: June 28, 2005 Received: June 29, 2005

Dear Dr. Ambrose:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and in your is of your finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known): K051752-

Device Name: Roche Elecsys ® Troponin T STAT

Indications For Use:

Immunoassay for the in vitro quantitative determination of troponin T in human serum and plasma. Elecsys Troponin T can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g., acute myocardial infarction. The test is further indicated for the risk stratification of patients presenting with acute coronary syndrome and for cardiac risk in patients with chronic renal failure. The test may also be useful for the selection of more intensive therapy and intervention in patients with elevated levels of cardiac Troponin T. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys family of immunoassay analyzers.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

| | <div>Division Sign-Off</div> <div> Office of In Vitro Diagnostic Device Page 1 of 1 </div> <div>Evaluation and Safety</div> |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Confidential | 510(k) K051752 |

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